Presentations made during the Joint Session of ... · Presentations made during the Joint Session...

Presentations made during the Joint Session of International Bioethics Committee (IBC) and the Intergovernmental Bioethics Committee (IGBC), held at UNESCO Headquarters in Paris on 28 and 29 October 2010

CONTENT

1. Promoting Bioethics: steps ahead – UNESCO´S role, by Ms Dafna Feinholz, UNESCO, Social and Human Sciences Sector

2. Principle of respect for human vulnerability and personal integrity:

progress report on the IBC working group, by Mr Stefano Semplici, IBC

3. La médecine traditionnelle et ses implications éthiques : Rapport préliminaire (In French)

4. Human Cloning and International Governance: Progress Report of the IBC

Working Group, by Mr Toivo Maimets, IBC The ideas and opinions expressed in these presentations are those of the authors and do not necessarily represent the views of UNESCO or its Members States

Promoting Bioethics:Promoting Bioethics:Steps ahead.Steps ahead.

UNESCOUNESCO´́S role.S role.Division of Ethics of Science and

Technology

Joint Session of the Joint Session of the International Bioethics International Bioethics

Committee (IBC) and the Committee (IBC) and the Intergovernmental Bioethics Intergovernmental Bioethics

Committee (IGBC)Committee (IGBC)28-29 October 2010

BackgroundBackground

In 1993: development of a formal programme

From 1993-2005: Standard Setting Action

• Universal Declaration on the Human Genome and Human Rights (1997, endorsed by the UN General Assembly in 1998)

• International Declaration on Human Genetic Data (2003)• Universal Declaration on Bioethics and Human Rights (2005).

From 2005:

Efforts to disseminate, promote, apply and elaborate the principles of the UDBHR

• Activities:

- Dissemination of the principles- Elaboration of the principles - Application of the principles

Primary focus of work:Implementation and follow-up of the Universal Declaration on Bioethics and Human Rights (adopted in 2005) in the Member States

I. ELABORATION OF THE PRINCIPLES.I. ELABORATION OF THE PRINCIPLES.

International Bioethics Committee: International Bioethics Committee:

Unique global intellectual forum for Unique global intellectual forum for a multidisciplinary, pluralistic and multicultural reflection ona multidisciplinary, pluralistic and multicultural reflection onethical and legal issues raised by reseethical and legal issues raised by researarch in life sciences and ch in life sciences and

thetheirir applications.applications.

Advisory role in:Advisory role in:

•• Capacity building Capacity building •• Education and awarenessEducation and awareness


2003 – Report of IBC on the Possibility of Elaborating a Universal Instrument on Bioethics 2003 – Report of IBC on Pre-implantation Genetic Diagnosis and Germ-line Intervention 2002 – Human Genetic Data: Preliminary Study by IBC on its Collection, Processing,

Storage and Use 2002 – Report of IBC on Intellectual Property and Genomics 2002 – Advice of IBC on the Patentability of the Human Genome 2001 – Report of IBC on Solidarity and International Co- operation between Developed and

Developing Countries concerning the Human Genome 2001 – The Use of Embryonic Stem Cells in Therapeutic Research 2000 – Report on Confidentiality and Genetic Data 1996 – Ethical Considerations regarding Access to on Human Gene Therapy 1994 – Report on Genetic Screening and Testing


Division de l’éthique des sciences et des technologies – Section Bioéthique

Universal Declaration onUniversal Declaration on Bioethics and Human RightsBioethics and Human Rights

Adopted by the General Conference of UNESCO in 2005

Article 25 – Follow-up action by UNESCO

1. UNESCO shall promote and disseminate the principles set out in this Declaration. In doing so, UNESCO should seek the help and assistance of the Intergovernmental Bioethics Committee (IGBC) and the International Bioethics Committee (IBC).


New Series:Publication of the reports of IBC related to the principles of the Universal Declaration on Bioethics and Human Rights

2008


New Series

Report of the International Bioethics Committee of UNESCO (IBC) ON SOCIAL RESPONSIBILITY AND HEALTHEnglish and French

2009


WWork Programme for the biennium 2010ork Programme for the biennium 2010--20112011

IBC will continue its work on:IBC will continue its work on:1.1.The principle of respect for human vulnerability aThe principle of respect for human vulnerability andnd personal personal

integrity (Art. 8)integrity (Art. 8)2. Human Cloning and International Governance 2. Human Cloning and International Governance (previous report (previous report

and discussions in Mexico city at the 17and discussions in Mexico city at the 17thth Session, 2009)Session, 2009)FFocusing on: ocusing on: Terminology and their ethical impactTerminology and their ethical impactDifferent options for legal regulation of human reproductive cloDifferent options for legal regulation of human reproductive cloningningPropossals for dissemination activities concening human cloning Propossals for dissemination activities concening human cloning

and international governanceand international governance3.Traditional medicine and its ethical implications3.Traditional medicine and its ethical implications

II. Application of Principles: Capacity building:

Assistance in reinforcing the ethics infrastructures

Three practical projects:Three practical projects:

•Assisting Bioethics Committees (ABC)

•Ethics Education Program (EEP)

•Global Ethics Observatory (GEObs)

Universal Declaration on Bioethics and Human Rights

Article 19. Ethics Committees

Independent, multidisciplinary and pluralist ethics committees should be established, promoted and supported at the appropriate level in order to:

a. Assess the relevant ethical, legal, scientific and social issues related to research projects involving human beings;

b. Provide advice on ethical problems in clinical settings;c. Assess scientific and technological developments, formulate

recommendations and contribute to the preparation of guidelines on issues within the scope of this Declaration;

d. Foster debate, education and public awareness of, and engagement in, bioethics.

Assisting Bioethics Committees Project (ABC) Main Objective: To reinforce bioethics infrastructure in Member States through facilitating the establishment of national bioethics committees,

and, once established, through the enhancement of their technical capacities

3 Steps of the ABC Project3 Steps of the ABC ProjectStep I. Exploration and assessment of the existing bioethics infrastructure

in the country

Step II. Technical support for the establishment of the national bioethics committee

Step III. Technical support for long-term sustainability

a. Technical capacity-building trainingsb. Partnerships, internships and networking

c. Provision of practical information

Assisting Bioethics Committees Project (ABC) Step III. Technical support for sustainability

a. Technical capacity-building trainings (3 trainings in 3 years)

Year 1• First training: Working Methods of NBCs• Building up relevant documentation • Training of the Committee’s secretariat• Team of experts: English, French & Spanish

Year 2• Second training: Bioethics – Principles and Practices (based on

UNESCO’s Core Curriculum in Bioethics)• Public event to disseminate the work of the committee

Year 3• Specialized ethics training (ethics education, legal provisions, etc)• Actions to ensure long-term sustainability and viability of the NBC

Assisting Bioethics Committees Project (ABC) Step III. Technical support

b. Partnerships, Internships and Networking

PartnershipsFacilitating the establishment of long-term partnerships between the experienced and newly established national bioethics committees, for sustained exchange of knowledge, experience and resources.

Togo and Swiss; Belgium and Guinea.

Arranging internships for the secretariat members of the newly established NBCs, hosted by experienced committees

Supporting networking opportunities at regional and international levels

Internships

Networking

European Commission-UNESCO Conference: Joint Action for Capacity-building in Bioethics

Mexico City, 26-28 November 2009Conference structured around three major themes:- Emerging bioethics issues- Building an international network- Engaging in ethical discourse

Over 100 participants from all regions of the world agreed on:

•Using and promoting the available resources, such as the databases of the UNESCO Global Ethics Observatory (GEObs), as platforms of exchange of knowledge and information

•Promoting regional bioethics networks that actively facilitate exchange of knowledge and best practices concerning bioethical issues of common concern

•PUBLICATION: NATIONAL BIOETHICS COMMITTEES IN ACTION: English and French (2010)


c. Provision of technical information

UNESCO Guides

Guide N°1: Establishing Bioethics CommitteesGuide N°2: Bioethics Committees at Work: Procedures and PoliciesGuide N°3: Educating Bioethics CommitteesGuide N°4: Ethics Committees and Public PoliciesGuide N°5: Ethics Committees and Public Debate

Available in English, French, Spanish, Russian, Arabic, Chinese, Turkish

Other materials

UNESCO, in partnership with the Kennedy Institute of Ethics (Georgetown University) and the Commission nationale d’éthique du Québec. IBC REPORT


c. Provision of technical information

UNESCO Guides

Guide N°1: Establishing Bioethics CommitteesGuide N°2: Bioethics Committees at Work: Procedures and PoliciesGuide N°3: Educating Bioethics CommitteesGuide N°4: Ethics Committees and Public PoliciesGuide N°5: Ethics Committees and Public Debate

Available in English, French, Spanish, Russian, Arabic, Chinese, Turkish

SURVEY 80% NBC used Guide 1, 60% Guide 2, 40% Guide 30% ,. All: “Very satisfied or Satisfied”. 74% have used UNESCO publication for the last 2 years.

Assisting Bioethics Committees Project (ABC) Present state of the ABC Project

Countries that have already established NBC Countries considering the

establishment of NBC

El Salvador (2010)Malasya (2010)Jamaica (2009)Colombia (2009)Ivory Coast (2002)El Salvador (2009)Gabon (2008)Ghana (2009)Kenya (2009)Mali (2009)Oman (2009)Madagascar (2007)Guinea (2007)Togo (2007)

Cap-VerdeChadChinaComorosMalaysiaMalawi MauritiusNamibiaNigerNigeria Trinidad and Tobago

Assisting Bioethics Committees Project (ABC) Present state of the ABC Project

NBCs that have signed MoU with UNESCO (first training held in 2009)

Ivory Coast (first training Dec. 2009)

Gabon (first training June 2009)

Ghana (first training Jan. 2009)

Guinea (first training April 2009)

Jamaica (first training March 2009)

Kenya (first training Nov. 2009)

Togo (first training Jan. 2009)

The second training in ethics based on UNESCO’s Bioethics Core Curriculum (scheduled for 2010 and 2011)

Ivory Coast (27-29 Sep. 2010)

Guinea (March 2011)?

Jamaica (1-5 Nov. 2010)

Kenya (22-25 Nov 2010)

El Salvador (27/29Sept 2010 1stTraining)

Madagascar (First and second) ?Gabon (Abril 2011)Ghana (Spring 2011)Togo ( Spring 2011)



•Ethics Education Program (EEP)

Launched at 1993 and expanded in 2005:

Art. 23 UDBHR encourages Member States to “foster

bioethics education and training at all levels as well to

encourage information and knowledge dissemination

programmes about bioethics”

EEP Ethics Education Programme

Activities undertaken

1. mapping of experts in ethics

2. sampling of teaching programs

3. bioethics core curriculum

4. ethics teacher training course

5. ethics resources

Regional expert meetings:

• Budapest (2004)

• Moscow (2005)

• Split (2005)

• Tehran (2006)

• Muscat (2006)

• Istanbul (2007)

• Marrakech (2008)

• Abidjan (2008)

• Dakar (March 2009)

• Kinshasa (July 2009)

EEP Ethics Education Programme

Activities undertaken

1. mapping of experts in ethics

2. sampling of teaching programs

3. bioethics core curriculum

4. ethics teacher training course

5. ethics resources

Regional expert meetings for

2010-2011

- Barcelona

- Lisboa

- South Africa

- 3 Asia-Pacific

- 3 Latin America and the Caribbean

UNESCO Bioethics Core Curriculum

NEW• Based on principles of Universal

Declaration on Bioethics and Human Rights

• Proposes a minimum program

• Flexibility: does not impose a particular model

• Global outreach: useful in all regions

• Heterogeneity: variety and diversity around a common core

Aim: to facilitate the introduction of bioethics primarily in medical and science schools

UNESCO Bioethics Core Curriculum

NEW• Largely adopted by Standing Committee of

European Doctors (CPME)

• Used for the revision of medical ethics and law curricula in the U.K and backed up by the General Medical Council of the UK and the British Medical Association

• Essential component of Master in Bioethics of the National Guard Health Affairs in Saudi Arabia

Aim: to facilitate the introduction of bioethics primarily in medical and science schools

UNESCO Bioethics Core Curriculum Potential Test Sites (interested universities):• Africa:

• 3 interested universities (details being discussed)• Arab States:

• 2 interested universities (details being discussed)• Asia and the Pacific:

• 5 MOUs signed, more being discussed• Europe and North America:

• 4 MOUs signed, more being discussed• Latin America and the Carribean:

• 1 MOU signed, 2 interested universities (details being discussed)•PROBABLE GLOBAL DEPLOY 2011



GLOBAL ETHICS OBSERVATORY (GEOBS)Survey in Mexico City in 2009 76% (N=375) :

•Very Satisfied or Satisfied

•Six data bases being used on regular basis

•24% to find resources on ethics

•20% to identify teaching programs

•Top users: 42% Europe, Asia (19%) and Latin America (15%)

last two rapidly increasing.

GEObs

Global Ethics Observatory

• Database 1: experts (Who is who in ethics?)

• Database 2: institutions, organisations, commissions

• Database 3: ethics teaching programmes

• Database 4: legislation

• Database 5: codes of conduct

• Database 6: resources in ethics

Freely accessible

6 languages: Arabic, Chinese, English, French, Russian, Spanish

www.unesco.org/shs/ethics/geobs

experts 1406

institutions 437

programmes 230

22 countries; 468 instruments

151 codes

resources 212

GEObs

Global Ethics Observatory

• Database 1: experts (Who is who in ethics?)

• Database 2: institutions, organisations, commissions

• Database 3: ethics teaching programmes

• Database 4: legislation

• Database 5: codes of conduct

• Database 6: resources in ethics

Accessed more than 53891 times + than 13642 unique user.

55848 searches, data view 822921

www.unesco.org/shs/ethics/geobs

experts 1406

institutions 437

programmes 230

22 countries; 468 instruments

151 codes

resources 212

UNESCO Chairs and Regional Documentation Centres

They assist the Organization in the implementation of the EEP. •Some of the UNESCO Chairs in Bioethics are currently located in •Barcelona (Spain) Mapping (2010-11)•Brasilia (Brazil), •Egerton (Kenya), Ethics teaching, mapping (2011)•Haifa (Israel), Ethics teaching•Porto (Portugal), Mapping 2010-11)•Rome (Italy) Mapping (2010-11). Recently established:•Côte d’Ivoire,•New chairs are in the process of establishment Oman, Sudan and Slovan Repubic. •EXOLORING ESTABLISHMENT NETWORK OF CHAIRS: (MAY 2010)


•ETHICS TEACHING TRAINING:•CHAIRS IN ISRAEL AND KENYA:•Romania 2006•Kenya 2007•Slovakia 2007•Saudia Arabia 2007•Belarus 2008•Croatia 2010•PLANNED FOR 2011•Kenya•Ethiopia•NamibiaESTABLISHMENT OF AN INTERNATIONAL SOCIETY FOR EDUCATIONS IN ETHICS (FIRST MEETING PARIS 2010)


•Regional Documentation Centres:

• Are an important resource for future activities

•They will make information and documentation from the region itself available and distribute information materials from other regions and UNESCO.

•Centres have been established in:

•Vilnius (Lithuania)

• Eagerton (Kenya).

•New one will be established in Cairo (Egypt)


•Vilnius (Lithuania)

Translation into Russian of Geobs

Ehtics Information Centers and Mass media: Fostering Bioethics Public Debate: Workshop 2009

• Eagerton (Kenya).

Conference on Bioethics Perspectives in Research, Life Sciences and Related Technologies in Sub-Saharan Africa.

III. DisseminationPublications - February 2009: English version

-French translation ready

-Director of the Division and IBC member

Each chapter focused on one Article analyzing 3 questions:

1. Why is this Article in the Declaration?

2. What does the Article mean in the context of the Declaration?

3. How can the Article be applied?

La Declaración Universal sobre bioética y Derechos Humanos de la UNESCO. Gros Espiell, Héctor and Gómez Sánchez Yolanda, coord. Editorial: Comares. 2006. Prologue by Mr.Koichiro Matsuura. Introductory chapter: Mr. Federico Mayor.

Sobre la Dignidad y los Principios. Análisis de la Declaración Universal de Bioética y Derechos Humanos de la UNESCO Casado María Editorial, Coord. Civitas, Navarra, 2009,

III. DisseminationPublications

-UNESCO CHAIRS, EX IGBC MEMBERS.

III. DISSEMINATION OF PRINCIPLES

Meetings organized by Chairs:

Zefat, Israel (May 2009): International Conference on Ethics Committees, organized by the UNESCO Chair in Bioethics in University of Haifa

- Brasilia, Brazil (August 2009): Seminar on National Council of Bioethics, organized by the UNESCO Chair in Bioethics in University of Brasilia


• Public events during ABC trainings

Universidad Centroamericana

Jose Simeon Cabanas, El Salvador, September 28, 2010:

Universal Declaration of Bioethics and Human Rights and its relation to other normative instruments

Role of National Commissions of Bioethics and Public Policies. Regional and International perspectives.

Role of National Commissions of Bioethics and Education.

INTERANTIONAL COOPERATION INTERANTIONAL COOPERATION AND COORDINATION AND COORDINATION UN InterUN Inter--Agency Committee on BioethicsAgency Committee on Bioethics

2003. UNESCO permanent Secretariat2003. UNESCO permanent Secretariat

Members: OHCHR, UNU, FAO, ILO, UNESCO, WHO, WIPOAssociate Members: ALECSO, CoE, EC, ICGEB, AU, OECD, WTO

Promotes coordination and cooperation in the activities and identifies areas of cooperation to enhance the impact of activities through coordinated and interactive approaches.

ONGOING ACTIVITIES:COOPERATION IN THE FIELD OF CAPACITY BUIDING AND NATIONAL BIOETHICS

COMMITTEES.

RECENT ISSUE:

The Economic and Social Council considered the issue of genetic privacy and non- discrimination at its 2001, 2004, 2007 and 2008 sessions. At its substantive session of 2008 the Council adopted the ECOSOC decision 2008/233 by which it:………

• Plan of action

• To carry on with the consultations with Member States on relevant developments in the field of genetic privacy and non-discrimination and on a possible inter-agency coordination mechanism.

• To continue the consultation with other UN agencies, extended to other relevant intergovernmental organizations, on the implementation of activities relevant to genetic privacy and non-discrimination. (Meeting 2011).

ETHICS OF SCIENCE AND ETHICS OF SCIENCE AND TECHNOLOGYTECHNOLOGY

Our website:

www.unesco.org/bioethics

Principle of respect for human vulnerability and

personal integrity:

progress report on the IBC working group

Stefano Semplici

Article 8Article 8

• In applying and advancing scientific knowledge, medical practice and associated technologies

• Human vulnerability should be taken into account

• Individuals and groups of special vulnerability should be protected

• And the personal integrity of such individuals respected

Our task is not to develop an in-depth “philosophical” reflection on the concept of vulnerability as a general feature of the human condition. This concept is rather intended as the background of the challenge addressed in Article 8.

Fragility is an essential anthropological dimension both for individuals and the shaping of human relationships.. To take into account human vulnerability means to acknowledge that we all may lack at some point the ability or the means to protect ourselves, our health and body, our life. We are all confronted with disease, disability, environmental risks. At the same time, we over and over experience the possibility that harm and even death come from other human beings.

We are all “committed” one to another. To take into account vulnerability implies a shift from a rights- based to a duties-based interpretation and “protection” of human dignity. Especially with regard to those people who are “of special vulnerability” and are more likely to find themselves in a position in which they simply cannot say “no”. We point out three fundamental criteria to address this “special” responsibility and obligation.

A) Special (temporary or permanent) conditions of human life (children, patients with diminished cognitive abilities, mentally ill patients, etc…).

B) Human and social determinants: culture, tradition, economy, power.

C) Nature and environment.

The special relevance of human and social determinants

• Inequalities in income, social conditions, education

• Discrimination and marginalization (e.g. the immigrant people)

• Consequences of the exploitation of resources in developing countries

• Trade-off between the right of every human being to quality health care and other rights whose protection directly or indirectly impinges upon the sharing of benefits of scientific progress (e.g. intellectual property).

Despite the philosophical difficulties involved in the concept, we easily recognize vulnerability when it arises.

At the same time, we recognize its essential connection with the concept of integrity (which needs a further elaboration in the Report).

Therefore, the method is “illustrative”. We provide and discuss examples of vulnerability with regard to the three domains pointed out in Article 8.

Vulnerability in the clinical setting

A) The general condition of asymmetry in the physician-patient relationship.

B) The issue of self-determination and consent.

C) The lack of access to proper health care.

D) The effects of widespread “malpractice”.

Vulnerability in human subject research

In this context, the additional safeguard of the physician’s primary focus being on restoring the patient to health is absent.

A) The issue of business and conflict of interests.

B) Coercion arising from a number of sources in the recruitment of healthy volunteers.

C) Omission of relevant information about possible risks.

D) Deliberate exclusion of certain groups from participation in research (e.g. children and pregnant women).

Vulnerability in the development and application of biotechnology

Controversial developments such as stem cell research and therapy, therapeutic cloning and gene therapy may promise progress in healthcare capacities for the future, but they also pose special problems for current and future individuals and groups whose social, personal and health status may be affected, rendering them socially and politically vulnerable.

General suggestionsWe should:

• Avoid references to single authors and scholars in the Report (especially references from one and the same tradition and culture).

• Clarify the connection with documents related to the same topic and produced by United Nations, Unesco and other international organizations, avoiding superfluous overlapping (e.g. the Report of the IBC on Consent).

• Include an Annex (as in the case of the Report on Social responsibility) to provide a wide review on the juridical framework both at the national and the international level.

• Further elaborate the examples. Some of them are actually misleading.

La médecine traditionnelle et ses implications éthiques

Rapport préliminaire

Pourquoi un rapport du CIB sur la médecine traditionnelle?

MT évoquée à plusieurs reprises lors des débats au sein du CIB en tant que thème particulièrement important pour les pays en développement et leurs comités nationaux de bioéthiqueMT est utilisée par une grande majorité des populations des pays en développementPeu de pays ayant des réglementations relatives aux médicaments à base de plantes

LA CREATION DU GROUPE LA CREATION DU GROUPE DE TRAVAILDE TRAVAIL

Le Bureau du Comité international de bioéthique (CIB), lors de sa réunion de mars 2010, a décidé d’inscrire l’éthique et la médecine traditionnelle au programme de travail du CIB pour 2010-2011.

1ère réunion en juin 2010

LA COMPOSITION DU LA COMPOSITION DU GROUPE DE TRAVAILGROUPE DE TRAVAIL

Dr. Emilio La Rosa, prDr. Emilio La Rosa, préésident du groupesident du groupeProf. Fouad BoustanyProf. Fouad BoustanyDr. ADr. Aïïssatou Tourssatou Touréé

Pour lPour l’é’étude des castude des casProf. HuProf. HuProf. BoiroProf. BoiroProf. MassougbodjiProf. Massougbodji

SOMMAIRE

1 INTRODUCTION1 INTRODUCTION

2 CONSID2 CONSIDÉÉRATIONS GRATIONS GÉÉNNÉÉRALESRALES

2.1 D2.1 Dééfinitionsfinitions

2.2 Typologie de la m2.2 Typologie de la méédecine traditionnelledecine traditionnelle

2.3 2.3 ÉÉtat de la situationtat de la situation

2.4 M2.4 Méédecine traditionnelle et mdecine traditionnelle et méédecine conventionnelle decine conventionnelle : approches et perspectives : approches et perspectives

2.5 M2.5 Méédecine traditionnelle : bdecine traditionnelle : béénnééfices et risquesfices et risques

2.6 M2.6 Méédecine traditionnelle et systdecine traditionnelle et systèèmes de santmes de santéé

SOMMAIRE (suite)

3 IMPLICATIONS 3 IMPLICATIONS ÉÉTHIQUES DE LA MTHIQUES DE LA MÉÉDECINE DECINE TRADITIONNELLETRADITIONNELLE

3.1 Principes 3.1 Principes ééthiques de la Dthiques de la Dééclaration universelle claration universelle sur la biosur la bioééthique et les droits de lthique et les droits de l’’hommehomme

3.2 Pratique de la m3.2 Pratique de la méédecine traditionnelle : decine traditionnelle : éétudes tudes de casde cas

3.3 Recherche en m3.3 Recherche en méédecine traditionnelledecine traditionnelle

3.4 Formation, 3.4 Formation, éévaluationvaluation

4 CONCLUSIONS4 CONCLUSIONS

LE POURQUOI

• Le développement et l’importance sanitaire et économique de la médecine traditionnelle, ainsi que son ancrage dans l’histoire et les cultures des peuples,

• L’absence de normes éthiques relatives à la pratique traditionnelle dans bon nombre des pays

• L’OMS considère que la médecine traditionnelle doit être intégrée au système de santé en respectant un certain nombre d’exigences: innocuité, efficacité, qualité, usage rationnel.

La mLa méédecine traditionnelle dans decine traditionnelle dans les pays en dles pays en dééveloppementveloppement

En Afrique, 80% de la population utilise la médecine traditionnelle pour des raisons culturelles ou parce qu’il n’y a pas une autre alternative.

En Chine, ⇛ ⇛ 40% des soins de santé correspond à la médecine traditionnelle,⇛ ⇛ 30 à 50% de la consommation totale de médicaments correspondent aux préparations àbase de plantes,⇛ ⇛ 200 millions de personnes utilisent la médecine traditionnelle.

La MT permet une facilité d’accès, une disponibilitéet un bas coût

LL’’utilisation de la MT pour utilisation de la MT pour les soins de santles soins de santéé primaireprimaire

60

60

70

70

80

90

0 20 40 60 80 100

Ougande

Tanzanie

Rwanda

Inde

Bénin

Ethiopie

Source : OMS

La mLa méédecine traditionnelle et decine traditionnelle et alternative dans les pays industrialisalternative dans les pays industrialisééss

Le pourcentage de personnes qui font appel à la médecine alternative augmente avec la croyance que tout ce qui est naturel n’a pas de danger et aussi parce que la médecine traditionnelle est un complément dans le cas de maladies chroniques.

Aux États Unis: ⇛ ⇛ 158 millions d’adultes ont utilisé, au cours de leur vie, un remède traditionnel, et ⇛ ⇛ en 2000, la population a dépensé plus de 17 milliards de dollars en remèdes traditionnels

Population ayant eu recours Population ayant eu recours àà la la mméédicine alternative au moins une foisdicine alternative au moins une fois

31

42

48

4970

0 10 20 30 40 50 60 70

Belgique

USA

Australie

France

Canada

Source : OMS

LL’’absence des normesabsence des normesSource : OMS 2001

RRééglementation des mglementation des méédicaments dicaments àà base de plantesbase de plantes

Typologie de la MT

Thérapies médicamenteuses: à base de plantes, produits animaux, minérauxThérapies non médicamenteuses : manuelles, physiques, mentales, spirituelles. Parfois font l’objet de conceptualisation voire codificationThérapies mixtes basées sur le mysticisme, croyances diverses avec ou non des supports physiques (potions) et pratiques variées

Médecine traditionnelle versus médecine conventionnelle: approches et perspectives

MT: • propre d’un peuple, d’une culture• raisonnement analogique, approche

holistique du pathologique• Existe composante sociale de la maladie

MC:• Construites sur des connaissances

scientifiques, basées sur des preuves• Approche fragmentaire la plupart du temps• S’attaque aux troubles fonctionnels

Médecine traditionnelle: atouts et contraintes

Atouts:• Accessibilité• Coût plus abordable• Approche holistique

Contraintes:• Difficulté à évaluer formation et savoir

tradi-praticien• Difficulté à évaluer toxicité à long terme• Difficulté à évaluer effets secondaires• Difficulté à standardiser les dosages

MMéédicine traditionnelle dicine traditionnelle et systet systèèmes de santmes de santéé des paysdes pays

La médecine traditionnelle vis-à-vis du système de santé:

Intégrée et reconnue: Chine, République de Corée, République populaire démocratique de Corée et VietnamReconnue : mais pas intégrée au système de santé: Inde, Indonésie, Ghana, Nigeria, Mali, Canada,..Tolérée : la plupart des pays

Implications éthiques de la médecine traditionnelle

L’approche éthique de la médecine traditionnelle est faite à partir

d’un certain nombre des principes énoncés dans la Déclaration

universelle sur la bioéthique et les droits de l’homme

Articles à prendre en compte

Article 3 - Dignité humaineArticle 4 - Effets bénéfiques et nocifsArticle 5 - Autonomie et responsabilitéindividuelleArticles 6 et 7 - Consentement et personnes incapables d’exprimer leur consentementArticle 8 – Respect de la vulnérabilitéhumaine et de l’intégrité personnelle

Articles à prendre en compte

Article 9 - Vie privée et confidentialitéArticle 12 - Respect de la diversitéculturelle et du pluralismeArticle 14 – Responsabilité sociale et santéArticle 17 - Protection de l’environnement, de la biosphère et de la biodiversitéArticle 20 - Évaluation et gestion des risques

Pratique traditionnelle : études des cas

Les syndromes psychosomatique-culturels: La symptomatologie clinique peut cacher une maladie grave. • Exemple, les « susto » (peur): perte d’appétit, malaise,

perte de poids, anémie, troubles nerveux, fièvre, nausées, vomissements, diarrhées,…

La phytothérapie: Le manque de réglementation, contrôle et pharmaco-vigilancepeut provoqué des dégâts sur la santé.• Exemple, l’éphédra, plante utilisé pour la congestion

des voies respiratoire. Un usage excessive a provoque des troubles cardio-vasculaires (infarctus du myocarde, mort subite) et neurologiques (AVC).

Pratique traditionnelle : études des cas

Les pathologies (visibles) : les diagnostics tardifs des maladies graves• Exemples, le cas d’un tumeur oculo-orbitaire

(carcinome baso-cellulaire), la patiente avait été vu par deux tradipraticiens depuis le début de la maladie. Ceux-ci avaient estimé que l’affection était due à de mauvais sorts jetés au patient par un membre de sa famille. Pendant 9 mois, elle avait reçue des traitements sous forme de scarifications, mixtures et incantation.

Recherche en médecine traditionnelle (A développer)

Quelles médecines traditionnelles peuvent faire l’objet de recherche?Doit-on et peut-on appliquer les mêmes principes d’évaluationDoit-on et peut-on appliquer les mêmes principes d’éthique de la recherche que pour la médecine occidentaleQui doit mener ces recherches?

Formation, évaluation, réglementation (A développer)

Quelles médecines traditionnelles peuvent faire l’objet d’évaluation?Comment évaluer la formation des praticiensQuels outils pour évaluer et sur quels critèresPar qui?Faut-il réglementer toutes les MT?Comment?

PRESENTATIONS COMPLEMENTAIRES

PROF GODFREY TANGWA

Ambiguïté du terme « médecine traditionnelle qui recouvre différents conceptsNécessité de clarifier les conceptsPas de différence dans les principes qui doivent guider la pratique de la MTNécessité de mise en œuvre d’une « égalité morale » et d’un respect des systèmes autresPossible modernisation/évaluation de la MT Nécessité d’étudier modalités

MS Serena Heckler UNESCO Secteur Sciences

Exactes et Naturelles

Rappel de réglementations et travaux dans le domaine des savoirs traditionnelsRecommandation de capitaliser les expériences des structures qui ont essayéde réguler la MTRecommandation d’inclure des praticiens de la MT dans le groupe de travail Recommandation d’inclure des utilisateurs la MT dans le processus de travail Suggestion pour une collaboration au niveau local plutôt que des normes internationales

Mme Schutnuttgen UNESCO Secteur Culure

Rappel d’un certain nombre de instruments internationaux concernant la diversité culturelleRappel des concepts et principes qui sous tendent la protection de la diversité culturelle.

Egale dignité et valeur de toutes les culturesTM comme une part intégrale de la diversitéculturelleNécessité d’un dialogue interculturelNécessité de considérer des recommandations de l’OMS concernant la MT (innocuité, efficacité, qualité, usage rationnel) en prenant en compte les conceptions propres à chaque système de valeur

Quelques suggestions retenues

Nécessité d’une meilleure compréhension des différents types de médecine traditionnellePréciser/circonscrire le champ d’études (TM vs MCA)Equilibrer les cas présentésDiscuter : le partage des bénéfices potentiels de la MT vs risques de biopiratageEviter aussi bien « l’angélisme » v-à-v MT qu’une position trop « parternaliste »

HUMAN CLONING AND INTERNATIONAL GOVERNANCE: PROGRESS REPORT OF

THE IBC WORKING GROUP

Toivo Maimets

IBC Co-chair and Chairman, IBC Working Group on Human Cloning and

International Governance

International Bioethics Committee 17th Session, Paris 26-27 oct. 2010

BACKGROUND

-Aug. 2001 UN GA 56th SessionPermanent Missions of France and Germany: International Convention against the Reproduc-tive Cloning of Human Beings

-March 2005, UN Declaration on Human Cloning 84 countries YES34 countries AGAINST37 countries ABSTAINING

ambivalent wordinglinking issues of reproductive and non-

reproductive cloning

BACKGROUND

-2007 UNU Institute of Advanced Studies:Is Human Cloning Inevitable: Future Options for UN Governance

Further development of international gover-nance is needed. IBC?

- DG UNESCO expresses his wish that UNU-IAS Report will be discussed by IBC

- January 2008 IBC Bureau includes the issue intoWork Programme 2008-2009 and establishes aWorking Group

THE WORKING GROUP

Prof. (Mrs) Ephrat Levy-Lahad (Israel)Prof. (Mr) Ching-Li Hu (China)Prof. (Mr) Gamal Ibrahim Abou Serour (Egypt)Prof. (Mr) Fernando Lolas Stepke (Chile)Prof. (Mr) Toivo Maimets (Estonia), Chairperson

MANDATE OF THE WG:

“...to explore whether there is any scientific, social or political change that would justify a new initiative at the international level, rather than to initiate another ethical and scientific analysis of the issue of human cloning.”

-HEARINGS on the 15th Session of IBC October 28-29, Paris

ACITVITIES OF THE WG

-Meeting June 30- July 2, 2008, Paris HEARINGS

- 15th Session of IBC (Paris Oct 27-29, 2008)

- Joint Session of IGBC (36 Member States) and IBC,Paris Oct 30-31, 2008

- REPORT of IBC on Human Cloning and InternationalGovernance (9.06.09)



- Intergovernmental Bioethics Committee 6th SessionParis 09.-10.07.09

- IBC Sixteenth session, Mexico City, Mexico, Nov 23-25,2009

REPORT OF IBC ON CLONING AND INTERNATIONAL GOVERNANCE

SHS/EST/CIB-16/09/CONF.503/2 Rev. 9. June 2009

I. BACKGROUND AND MANDATEII. THE UNU-IAS REPORTIII. PRESENT SITUATION OF THE INTERNATIONAL

GOVERNING OF HUMAN CLONINGIV. WORK CARRIED OUT BY IBC IN 2008-2009V. NEW SCIENTIFIC, LEGAL AND SOCIAL DEVELOPMENTS:

A PRELIMINARY ANALYSISVI. SUMMARY AND CONCLUSIONS

ANNEXStudy on National Legislation concerning Human Cloning

PRESENT SITUATION:

OF THE INTERNATIONAL GOVERNANCE OF HUMAN CLONING

- 3 UN declarations:

Universal Declaration on the Human Genome and Human Rights (1997)United Nations Declaration on Human Cloning (2005)Universal Declaration on Bioethics and Human Rights (UNESCO, 2005).

- WHO resolutions (1997 and 1998)

PRESENT SITUATION:

AT THE REGIONAL LEVEL

- Oviedo Convention (1997), Council of Europe

- Additional Protocol to Oviedo Convention (1998).

- Pact of San Jose, Costa Rica (1969)

PRESENT SITUATION:

National Regulations are diverse and reflect different cultural, religious, social and political

backgrounds (see ANNEX)

IBC CONCLUSIONS 2009:

On the basis of reflection and debate held in 2008-2009, IBC has been able to identify the following:

- Changes have occurred in the last three years that may have an impact on future development of international governance of cloning:

1. new scientific developments such as research on induced Pluripotent Stem (iPS) cells and itsapplication; production of sperm cells from embryonic stem cells (=in vitro derived sperm) etc.

2. increased international exchange (both legal and illegal) of embryos, eggs and stem cells;

IBC CONCLUSIONS 2009:Changes have occurred

3. increased public sensitivity and awareness Together with the development of national regulations of governance of human cloning and embryo research in general.


- The terminology used in the bioethical debates is misleading and does not adequately describe the technical procedures used (or potentially to be used) today. An in-depth analysis aiming at re-defining this terminology according to the new developments in human embryo research would be highly beneficial.

- National regulations of governance of human cloning and embryo research in general adopted so far confirm the convergence of views on the refusal to adopt legislation or guidelines permitting reproductive cloning, while they still show variationson the legitimacy of human cloning carried out as part of research agendas.


- The issues surrounding the international governance of human cloning cannot be ignored and a focused international dialogue is crucially needed.

- UNESCO is in a privileged position to continue this reflection in a way that accommodates the multiplicity of views on the issue and explore the ethical aspects of new scientific developments and their impact on the present international normativeframework.

SIXTH SESSION OF THEINTERGOVERNMENTAL BIOETHICS COMMITTEE (IGBC)

Paris, 9 – 10 July 2009

Conclusions of the 6th Session of the IGBCIn relation to the Report of IBC on Human Cloning and International Governance(Ref.SHS/EST/CIB-16/09/CONF.503/2 Rev. of 9 June 2009),

10. Acknowledges and values the work carried out by IBC on human cloning andinternational governance, congratulates IBC for an inclusive and balanced report onthe topic and invites the Secretariat to continue updating the annex to this document.

11. Concurs with IBC that an international dialogue on the international governance ofhuman cloning is needed and should be pursued, and that the dissemination,discussion and debate on cloning issues at the international level remain essential tofoster public sensitivity and awareness-raising, with a special attention to developingcountries.

12. Supports the assessment of IBC that an in-depth analysis aiming at reviewing theterminology for human cloning according to the new developments in biomedicalresearch would be highly beneficial.

13. Suggests that in pursuing its reflections on human cloning, IBC considers reviewingthe terminology for human cloning as well as a wide range of related issues such asother possible options for its regulation and the vulnerability of women.

-Bureau of IBC meeting, March 2010 to continue the work on human cloning and international governance in 2010-2011 by confirming and expanding the working group

Professor (Mr) Toivo Maimets, Chairperson of WGProf. (Mr) Abdallah Daar, Prof. (Mr) Qingli Hu, Prof. (Mr) Fernando Lolas Stepke, Prof. (Mr) Takayuki Morisaki, Prof. (Mr) Fawaz Saleh and Prof. (Mrs) Jeanine-Anne Stiennon.

The Working Group received mandate to focus on three main areas:

- terminology and its ethical impact (including reviewing the Report on the use of embryonic stem cells in therapeutic research, Ref. BIO-7/00/GT-1/2 (Rev. 3) of 6 April 2001);

- different options for legal regulation of human reproductive cloning (including the possibility of a moratorium); and

- proposals for dissemination activities concerning the issue of human cloning and its governance.

Meeting of the Working Group, June 7th-8th 2010, Paris

First draft Aug. 2010

1. INTRODUCTION

2. NEW SCIENTIFIC DEVELOPMENTS UNDERLYING THE RE-EVALUATION OF EXISTING INTERNATIONAL GOVERNANCE OF HUMAN CLONING

3. THE ISSUE OF TERMINOLOGY

4. ANALYSIS OF ALTERNATIVE METHODS OF INTERNATIONAL GOVERNANCE OF HUMAN CLONING

5. DISSEMINATION

6. EXECUTIVE SUMMARY

The IBC Working Group has been able to identify the following findings concerning international governance of human cloning:

b. Terminology

The use of the terms “therapeutic” or “research” cloning to describe the processof obtaining pluripotent stem cells should be avoided.

Instead, a term that describes the process rather than the intention behind it, such as “derivation of pluripotent cells” (by somatic cell nuclear transfer; re- programming (e.g. iPS) or any other existing or future technology) can be used. This terminology has an advantage of being descriptive, technically accurate, simple, easily understandable, and capable of incorporating any future scientific and technological developments. It also allows more nuanced and differentiated ethical analyses, depending on which technology is under scrutiny

c. Options for international governance

The existing legal framework applicable to international governance of human cloning is based on national and regional legislation and guidelines that prohibit various practices related to human cloning, as well as on non-binding instruments adopted by international organizations, such as the Declarations of UNESCO. Any moratorium on cloning under international law will have to relate to the existing norms in this area.

The current non-binding regulations can not be considered as sufficient in addressing the challenges posed by the contemporary developments related to human cloning. Therefore, there is a clear need to advance processes towards a more robust mechanism, such as a moratorium or a convention on prohibition on human reproductive cloning.

As an international organization that has a solid track record in standard-setting and capacity-building in bioethics, UNESCO provides the best global platform to initiate the processes towards a moratorium or a prohibition on human reproductive cloning under international law. Today, due to the sufficient consensus amongst governments of Member States against human reproductivecloning, it is plausible for UNESCO to move towards a convention prohibiting human reproductive cloning.

d. Dissemination

In order to promote the dissemination of information and to raise public awareness of the issues related to human cloning and its regulation, UNESCOcan pursue several actions, including:

• Creation of a database to serve as a clearinghouse of information and tomonitor new developments that affect the ethical aspects of human cloning debate; and

• Organization of a major Conference under the auspices of UNESCO,dedicated to the theme of human cloning and international governance.

THANK YOU

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